Samples From Patients With Enterococcal InfectionsNCT04777240
Characterization of Enterococci
An observational study of Samples From Patients With Enterococcal Infections, run by Sohag University at 1 site in Egypt.
Trial summary
Study on Characterization of Enterococci because nowadays it become an important cause of nosocomial infections .detection of the most common two species of Enterococci and most common virulence factors \& its genes with determination of antibiotics sensitivity test for the isolated strains Read more about this study
- Who is it for?
- Ages 2 months to 90 years
- Conditions the study is for
- Samples From Patients With Enterococcal Infections
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 10 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 90 years
- All sexes
- Child, Adult, Older adult
Study population: patients in ICU in Sohag University Hospital
Who may be able to join
- any patients in ICU has manifestations of urinary tract infections, surgical wound infections, intra-abdominal infections, intrapelvic infections, bacteraemia and infective endocarditis
Who cannot join
- patients receiving antibiotics in previous 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Enterococci; Distribution of Virulence Markers, Virulence Genes and Antibiotic Resistance Pattern of the Isolated Species
Study on Characterization of Enterococci because nowadays it become an important cause of nosocomial infections .detection of the most common two species of Enterococci and most common virulence factors \& its genes with determination of antibiotics sensitivity test for the isolated strains
What is being measured
The primary outcome is the main question the study is designed to answer.
I) Sample collection
Samples are collected from intensive care unit (ICU) including urine, pus swabs, sputum, blood, tracheal aspirates and pharyngeal swabs
Measured: 2 months
II) Identification of Enterococci:
by inoculation on Bile esculin azide \& growing colonies further identified by :
- microscopically after staining by gram stain
- catalase test
- grow on high concentration of NaCl (6.5%)
Measured: 2 month
III) Phenotypic detection of virulence marker of Enterococci(Gelatinase activity)
by culture on nutrient agar containing gelatin.Positive results appeared as liquefaction of gelatin
Measured: 2 weeks
IV)Phenotypic detection of virulence marker of Enterococci (hemolytic activity)
by Detection of hemolytic activity on the blood agar
Measured: 1 week
V) Phenotypic detection of virulence marker of Enterococci(Caseinase production)
by Detection of Caseinase production on Muller hinton agar containing skimmed milk 3%.
Measured: 2 weeks
VI) Phenotypic detection of virulence marker of Enterococci(Formation of Slime layer)
Formation of Slime layer by culture on Brain heart infusion agar containing 5% sucrose, plates are incubated for 24 hrs at 37oC. Positive strains gave mucoid and slimy colonies.
Measured: 1 week
VII) Phenotypic detection of virulence marker of EnterococcI (Biofilm formation)
using microtiter plate reader. Biofilm formation is scored as nonbiofilm forming (-), weak - (+), moderate - (++), and strong - (+++) corresponding to the A630 values ≤1, 1-≤2, 2-≤3, and>3, respectively
Measured: 2 weeks
VIII) Antibiotic sensitivity test:
- by 1- disc diffusion test using Vancomycin 30 μg, Teichoplanin 30 μg, Tetracycline 30 μg, Ampicillin 10 μg and Erythromycin 15 μg. Results ,Results are interpreted according to CLSI 2018.
- E-test:
MICs (minimal inhibitory concentrations) of Vancomycin are measured by E-test for confirmation of vancomycin resistance among the isolated Enterococci. Results are interpreted according to CLSI guidelines.
Measured: 3 monthe
IX) Molecular Identification of commonest Enterococcus species
by conventional gene specific uniplex PCR for E. faecalis and E. Faecium
Measured: 1 month
X) Molecular detection of virulence genes
Identification of virulence genes; gel E (gene for gelatinase), asa1 (gene for aggregation substance), cylA (gene for cytolysin activator), esp (gene for Enterococcal surface protein) Hyl (gene for Hyaluronidase) of E. faecalis and E. faecium was performed by uniplex PCR.The amplified products are visualized on 2% agarose gel stained with ethidium bromide. The stained gels are visualized and documented with a gel documentation system and analyzed visually to determine the size of PCR amplicons of the target genes directly by comparison with 100 bp DNA ladder marker.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Feb 2020
- Primary completion28 Feb 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Samples From Patients With Enterococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekram Abd El Rahman Mahmoud, Sohag University
- Investigators
- Ekram Ab Rahmand Mahmoud, lecturer, Principal investigator, Sohag Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777240
- Sponsor's protocol ID
- Soh-Med-21-02-19
- Status last verified
- Feb 2021
- First submitted
- 20 Feb 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Enterococci; Distribution of Virulence Markers, Virulence Genes and Antibiotic Resistance Pattern of the Isolated Species
- ClinicalTrials.gov ID
- NCT04777240
- Acronym / sponsor ID
- Soh-Med-21-02-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study on Characterization of Enterococci because nowadays it become an important cause of nosocomial infections .detection of the most common two species of Enterococci and most common virulence factors \& its genes with determination of antibiotics sensitivity test for the isolated strains
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 months to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients in ICU in Sohag University Hospital
Key inclusion criteria (1 listed)
- any patients in ICU has manifestations of urinary tract infections, surgical wound infections, intra-abdominal infections, intrapelvic infections, bacteraemia and infective endocarditis
Key exclusion criteria (1 listed)
- patients receiving antibiotics in previous 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
I) Sample collection
Time frame: 2 months
Samples are collected from intensive care unit (ICU) including urine, pus swabs, sputum, blood, tracheal aspirates and pharyngeal swabs
II) Identification of Enterococci:
Time frame: 2 month
by inoculation on Bile esculin azide \& growing colonies further identified by : 1. microscopically after staining by gram stain 2. catalase test 3. grow on high concentration of NaCl (6.5%)
III) Phenotypic detection of virulence marker of Enterococci(Gelatinase activity)
Time frame: 2 weeks
by culture on nutrient agar containing gelatin.Positive results appeared as liquefaction of gelatin
IV)Phenotypic detection of virulence marker of Enterococci (hemolytic activity)
Time frame: 1 week
by Detection of hemolytic activity on the blood agar
V) Phenotypic detection of virulence marker of Enterococci(Caseinase production)
Time frame: 2 weeks
by Detection of Caseinase production on Muller hinton agar containing skimmed milk 3%.
VI) Phenotypic detection of virulence marker of Enterococci(Formation of Slime layer)
Time frame: 1 week
Formation of Slime layer by culture on Brain heart infusion agar containing 5% sucrose, plates are incubated for 24 hrs at 37oC. Positive strains gave mucoid and slimy colonies.
VII) Phenotypic detection of virulence marker of EnterococcI (Biofilm formation)
Time frame: 2 weeks
using microtiter plate reader. Biofilm formation is scored as nonbiofilm forming (-), weak - (+), moderate - (++), and strong - (+++) corresponding to the A630 values ≤1, 1-≤2, 2-≤3, and>3, respectively
VIII) Antibiotic sensitivity test:
Time frame: 3 monthe
1. by 1- disc diffusion test using Vancomycin 30 μg, Teichoplanin 30 μg, Tetracycline 30 μg, Ampicillin 10 μg and Erythromycin 15 μg. Results ,Results are interpreted according to CLSI 2018. 2. E-test: MICs (minimal inhibitory concentrations) of Vancomycin are measured by E-test for confirmation of vancomycin resistance among the isolated Enterococci. Results are interpreted according to CLSI guidelines.
IX) Molecular Identification of commonest Enterococcus species
Time frame: 1 month
by conventional gene specific uniplex PCR for E. faecalis and E. Faecium
X) Molecular detection of virulence genes
Time frame: 2 months
Identification of virulence genes; gel E (gene for gelatinase), asa1 (gene for aggregation substance), cylA (gene for cytolysin activator), esp (gene for Enterococcal surface protein) Hyl (gene for Hyaluronidase) of E. faecalis and E. faecium was performed by uniplex PCR.The amplified products are visualized on 2% agarose gel stained with ethidium bromide. The stained gels are visualized and documented with a gel documentation system and analyzed visually to determine the size of PCR amplicons of the target genes directly by comparison with 100 bp DNA ladder marker.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekram Ab Rahmand Mahmoud, lecturer principal investigator
Sohag Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Samples From Patients With Enterococcal Infections, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I) Sample collection (time frame: 2 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.